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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3001 - A randomized phase II trial of adjuvant chemotherapy with gemcitabine versus S-1 after major hepatectomy for biliary tract cancer: Kansai Hepato-Biliary Oncology Group (KHBO1208)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Hepatobiliary Cancers

Presenters

Hiroaki Terajima

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

H. Terajima1, S. Kobayashi2, H. Nagano3, A. Tomokuni4, K. Gotoh2, D. Sakai5, E. Hatano6, S. Seo7, Y. Uchida8, T. Ajiki9, H. Satake10, K. Kamei11, T. Tohyama12, T. Hirose13, I. Ikai14, S. Morita15, T. Ioka16

Author affiliations

  • 1 Department Of Gastroenterological Surgery And Oncology, Kitano Hospital The Tazuke Kofu Kai Medical Research Institute, 530-8480 - Osaka/JP
  • 2 Department Of Surgery, Osaka University Graduate School of Medicine, Suita/JP
  • 3 Department Of Gastroenterological, Breast And Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi/JP
  • 4 Department Of Surgery, Osaka International Cancer Institute, Osaka/JP
  • 5 Department Of Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, Suita/JP
  • 6 Department Of Surgery, Hyogo College of Medicine, Nishinomiya/JP
  • 7 Department Of Surgery, Kyoto University Graduate School of Medicine, Kyoto/JP
  • 8 Department Of Gastroenterological Surgery And Oncology, Kitano Hospital The Tazuke Kofu Kai Medical Research Institute, Osaka/JP
  • 9 Department Of Surgery, Division Of Hepato-biliary-pancreatic Surgery, Kobe University Graduate School of Medicine, Kobe/JP
  • 10 Department Of Medical Oncology, Kobe City Medical Center General Hospital, Kobe/JP
  • 11 Department Of Surgery, Kindai University Faculty of Medicine, Osakasayama/JP
  • 12 Department Of Hepato-biliary-pancreatic And Breast Surgery, Ehime University Graduate School of Medicine, Touon/JP
  • 13 Department Of Surgery, Otsu Red Cross Hospital, Otsu/JP
  • 14 Department Of Surgery, National Hospital Organization Kyoto Medical Center, Kyoto/JP
  • 15 Department Of Biomedical Statistics And Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto/JP
  • 16 Department Of Cancer Survey And Gatrointestinal Oncology, Osaka International Cancer Institute, Osaka/JP
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Resources

Abstract 3001

Background

No adjuvant chemotherapy regimens after major hepatectomy for biliary tract cancer (BTC) have been standardized due to the frequency of adverse events. Survival benefits of adjuvant gemcitabine (GEM) or S-1 (S1) chemotherapy were investigated with the recommended dose determined in our previous clinical trial (KHBO1003), with 10% dose-limited toxicity.

Methods

We performed a phase II multicenter randomized trial. The primary end-point was 1-year recurrence-free survival (RFS), and the secondary end-points were other RFS, overall survival (OS), and others. The following 6-month adjuvant chemotherapy regimens were performed within 12 weeks after R0 or R1 major hepatectomy (hemihepatectomy or trisectionectomy) for BTC: GEM (1000 mg/m2) every 2 weeks or S1 (80 mg/m2/day) for 28 days every 6 weeks. Thirty-five patients were assigned to each arm (alpha error, 10%; beta error, 20%). P values of < 0.10 were considered to indicate a statistically significant difference.

Results

No patients were excluded for the per-protocol analysis. There were no statistically significant differences in the patient characteristics of the two arms. The 1-year RFS and the 1-year OS rates of the GEM arm were 51.4% and 80.0%, respectively, while those of the S1 arm were 62.9% and 97.1%, respectively. The 2-year RFS rate, the 1- and 2-year OS rates, and the OS curve of the S1 arm were superior to those of the GEM arm (p = 0.0894, p = 0.0242, p = 0.0679, and p = 0.0606, respectively), although the 1-year RFS rate was not significantly different (p = 0.334). With regard to the OS curve, the hazard ratio of the S1 group was 0.477 (90% confidence interval, 0.245-0.927).

Conclusions

The adjuvant chemotherapy with S1 may provide better survival benefits compared with that with GEM after major hepatectomy for BTC.

Clinical trial identification

NCT01815307 (March 21, 2013).

Legal entity responsible for the study

Kansai Hepato-Biliary Oncology Group.

Funding

Japan Society of Clinical Oncology Clinical research Grant Program 2012 and 2013.

Editorial Acknowledgement

Disclosure

I. Ikai, S. Morita: Lecture fee: Taiho Pharmaceutical Co., Eli Lilly Japan K.K. T. Ioka: Research funding, Lecture fee: Taiho Pharmaceutical Co. All other authors have declared no conflicts of interest.

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